For the treatment of adult patients with classical Hodgkin Lymphoma (cHL) that has relapsed or progressed after autologous stem cell transplantation (ASCT) and brentuximab vedotin, or 3 or more lines of systemic therapy including ASCT

Review Status

Notification to Implement Issued

Pre Noc Submission

Yes

NOC Date

November 10, 2017

Manufacturer

Bristol-Myers Squibb

Submitter

Bristol-Myers Squibb

Submission Date

September 29, 2017

Submission Deemed Complete

October 6, 2017

Submission Type

New Indication

Prioritization Requested

Requested and Not Granted

Stakeholder Input Deadline ‡

October 16, 2017

Check-point meeting

November 20, 2017

pERC Meeting

February 15, 2018

Initial Recommendation Issued

March 2, 2018

Feedback Deadline ‡

March 16, 2018

pERC Reconsideration Meeting

April 19, 2018

Final Recommendation Issued

May 3, 2018

Notification to Implement Issued

May 18, 2018

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.